Are you an experienced RA Officer, in search for an interesting career opportunity? Then we are looking for you! Our client is a pharmaceutical company, who is looking for a senior regulatory affairs specialist with deep knowledge about registration, legislation and regulation of biopharmaceutical products.
Job description
Do you want to work for an innovative pharmacuetical company in the Leiden Bioscience Park who has the patient's well-being as their top priority? This is your chance to take your RA career to the next level. Our client is seeking a highly motivated Regulatory Affairs Officer with expertise in pharmaceutical artwork content, legislation, and regulatory requirements. As the Regulatory Affairs Officer, you will be responsible for performing regulatory activities for in-vivo diagnostics and therapeutics for immunotherapy. The ideal candidate is an analytical, proactive individual with an eye for detail. You must be a team player, but also able to work independently and understand your profession. If you have a positive can-do attitude and a focus on continuous improvement, then we encourage you to apply for this position.
Responsibilities:
- Obtain, renew and adapt marketing authorizations in line with our client's marketing policy
- Compile full registration dossiers (Module 1 to 5) according to current demands in a way they can be submitted in the right format (electronically) to European Competent authorities
- Maintain and adapt existing registration dossiers and accompanying documents
- Submit requests for dossier changes (variations) in countries where registrations exist or named patient allowances are mandatory
- Prepare for national and international registration procedures
- Assess and compile Summary of Product Characteristics (SPCs), patient information texts and labelling of products
- Actively participate in project teams and bring forward regulatory issues
- Respond to questions from authorities
- Align and collaborate with Coordinator Artwork & Masterdata
Requirements:
- Academic education (bachelor or master) in (bio)science, pharmacy, or similar
- A minimum of 5 years relevant experience within Regulatory Affairs. Starters are not considered for this position
- Knowledge of biological or biotechnological products
- Experience with international registration procedures
- Adequate experience with electronic-eCTD
- Knowledge in the area of registration of drugs, specific knowledge in relation to legal aspects of drug registration
- Being capable of functioning well within project teams and communicating adequately with Authorities
- Sufficient knowledge of Dutch and English verbally and in writing
- Experience with Quality-related software applications is an advantage
Benefits:
- Competitive salary that matches your responsibilities and experience
- A 13th month salary
- Good secondary benefits
- A great, entrepreneurial, and friendly environment for self-starters, with ample opportunity for growth and development
- Location: Leiden, here they work on the full product pipeline from development to commercial production
